Package Leaflet: Information for the patient

Levetiracetam Strides 100 mg/ml oral

solution

Levetiracetam

Read all of this leaflet carefully before you or your child start taking this medicine

because it contains important information for you.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

•    What Levetiracetam Strides oral solution is and what it is used for

•    What you need to know before you take Levetiracetam Strides oral solution

•    How to take Levetiracetam Strides oral solution

•    Possible side effects

•    How to store Levetiracetam Strides oral solution

•    Contents of the pack and other information

1.    What Levetiracetam Strides oral solution is and what it is used for

Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Levetiracetam Strides 100 mg/ml oral solution is used:

•    on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat certain form of epilepsy. Epilepsy is a condition where the patients have repeated pits (seizures). Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalization). Levetiracetam has been given to you by your doctor to reduce the number of fits.

•    as an add-on to other antiepileptic medicines to treat:

o partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age

o myoclonic seizures (short, shock like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy o primary generalised tonic-clonic seizures (major fits, including loss of

consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

2.    What you need to know before you take Levetiracetam Strides oral solution

Do not take Levetiracetam Strides oral solution

•    If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in Section 6).

Warnings and precautions

Talk to your doctor before taking Levetiracetam Strides oral solution

•    If you suffer from kidney problems, follow your doctor’s instructions. He/she may decide if your dose should be adjusted.

•    If you notice any slowdown in the growth or unexpected puberty development of your child, please contact your doctor.

•    A small number of people being treated with anti-epileptics such as Levetiracetam Strides oral solution have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.

Children and adolescents

•    Levetiracetam Strides oral solution is not indicated in children and adolescents below 16 years on it’s own (monotherapy)

Other medicines and Levetiracetam Strides oral solution

Tell your doctor or pharmacist if you are taking or have recently taken or might take any

other medicines.

Do not take macrogol (a drug used as laxative) for one hour before and one hour after

taking levetiracetam as this may results in a reduction of its effect.

Concomitant administration of levetiracetam and methotrexate has been reported to decrease methotrexate clearance, resulting in increased/prolonged blood methotrexate concentration to potentially toxic levels. Blood methotrexate and levetiracetam levels should be carefully monitored in patients treated concomitantly with the two drugs.

Pregnancy and breast-feeding

If you are pregnant or breast feeding, think you may be pregnant, or planning to have a baby ask your doctor for advice before you taking this medicine.

Levetiracetam Strides oral solution should not be used during pregnancy unless clearly necessary. A risk of birth defects for your unborn child cannot be completely excluded. Levetiracetam Strides oral solution has shown unwanted reproductive effects in animal studies at dose levels higher than you would need to control your seizures.

Breast-feeding is not recommended during treatment.

Driving and using machines

Levetiracetam Strides Oral solution may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy. This is more likely at the beginning of treatment or after an increase in the dose. You should not drive or use machines until it is established that your ability to perform such activities is not affected.

Levetiracetam Strides oral solution contains methyl parahydroxybenzoate and maltitol

Levetiracetam Strides oral solution includes methyl parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed).

Levetiracetam Strides oral solution also contains maltitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Levetiracetam Strides oral solution

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Levetiracetam Strides oral solution must be taken twice a day, once in the morning and once in the evening, at about the same time each day.

Take the oral solution following your doctor’s instructions.

Monotherapy

Dose in adults and adolescents (from 16 years of age):

General dose: between 1,000 mg and 3,000 mg each day.

When you will first start taking Levetiracetam Strides oral solution, your doctor will prescribe you a lower dose (500 mg each day) during 2 weeks before giving you the lowest general dose of 1000 mg.

Add-on therapy

Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more:

General dose: between 10 ml (1,000 mg) and 30 ml (3,000 mg) each day, divided in 2 intakes per day.

Dose in infants (6 to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according to the age, weight and dose.

General dose: between 0.2 ml (20 mg) and 0.6 ml (60 mg) per kg bodyweight each day, divided in 2 intakes per day. The exact quantity of oral solution formulation should be delivered using the syringe provided in the cardboard box.

Weight	Starting dose: 0.1 ml/kg twice daily	Maximum dose: 0.3 ml/kg twice daily
6 kg	0.6 ml twice daily	1.8 ml twice daily
8 kg	0.8 ml twice daily	2.4 ml twice daily
10 kg	1 ml twice daily	3 ml twice daily
15 kg	1.5 ml twice daily	4.5 ml twice daily
20 kg	2 ml twice daily	6 ml twice daily
25 kg	2.5 ml twice daily	7.5 ml twice daily
From 50 kg	5 ml twice daily	15 ml twice daily

Method of administration:

Levetiracetam Strides oral solution may be diluted in a glass of water or baby’s bottle. You may take Levetiracetam Strides oral solution with or without food.

Instructions for use:

o Open the bottle: press the cap and turn it anticlockwise (figure 1)

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o Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure 3). Ensure it is well fixed.

o Take the syringe and put it in the adaptor opening (figure 4). Turn the bottle upside down (figure 5).

o Fill the syringe with a small amount of solution by pulling the piston down (figure 5A), then push the piston upward in order to remove any possible bubble (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (figure 5C).

o Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B).

o Empty the contents of the syringe in a glass of water or baby’s bottle by pushing the piston to the bottom of the syringe (figure 7).

o Drink the whole contents of the glass/baby’s bottle. o Close the bottle with the plastic screw cap. o Wash the syringe with water only (figure 8).

Duration of treatment:

•    Levetiracetam Strides oral solution is used as a chronic treatment. You should continue Levetiracetam Strides oral solution treatment for as long as your doctor has told you.

•    Do not stop your treatment without your doctor’s advice as this could increase your seizures.

If you take more Levetiracetam Strides oral solution than you should:

The possible side effects of an overdose of Levetiracetam Strides oral solution are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma. Contact your doctor if you took more Levetiracetam Strides oral solution than you should. Your doctor will establish the best possible treatment of overdose.

If you forget to take Levetiracetam Strides oral solution:

Contact your doctor if you have missed one or more doses.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Levetiracetam Strides oral solution:

If stopping treatment, Levetiracetam Strides oral solution should be discontinued gradually to avoid an increase of seizures.

Should your doctor decide to stop your Levetiracetam Strides oral solution treatment, he/ she will instruct you about the gradual withdrawal of Levetiracetam Strides oral solution.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The most frequently reported adverse reactions were nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness. At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common. These effects should however decrease over time.

Very common (may affect more than 1 users in 10 people):

•    nasopharyngitis;

•    somnolence (sleepiness), headache.

Common (may affect 1 to 10 users in 100 people):

•    anorexia (loss of appetite);

•    depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;

•    convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary trembling);

•    vertigo (sensation of rotation);

•    cough;

•    abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;

•    rash;

•    asthenia/fatigue (tiredness).

Uncommon (may affect 1 to 10 users in 1000 people):

•    decreased number of blood platelets, decreased number of white blood cells;

•    weight decrease, weight increase;

•    suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger, confusion, panic attack, emotional instability/mood swings, agitation;

•    amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/ ataxia (impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration);

•    diplopia (double vision), vision blurred;

•    elevated/abnormal values in a liver function test;

•    hair loss, eczema, pruritus;

•    muscle weakness, myalgia (muscle pain);

•    injury.

Rare (may affect 1 to 10 users in 10,000 people):

•    infection;

•    decreased number of all blood cell types;

•    Severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke’s oedema [swelling of face, lips, tongue and throat]);

•    decreased blood sodium concentration;

•    suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate);

•    uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);

•    pancreatitis;

•    liver failure, hepatitis;

•    skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens- Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis).

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at: ww.mhra.gov.uk/ yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Levetiracetam Strides oral solution

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the cardboard box and bottle after EXP: The expiry date refers to the last day of the month.

Do not use after 7 months of first opening the bottle.

Store in the original bottle, in order to protect from light Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Levetiracetam Strides oral solution contains

-    The active substance is called levetiracetam. Each ml contains 100 mg of levetiracetam.

-    The other ingredients are: sodium citrate (E331), citric acid monohydrate (E330), methyl parahydroxybenzoate (E218), ammonium glycyrrhizate (E958), glycerol (E422), maltitol liquid (E965), acesulfame potassium (E950), flavour natural white grape, purified water.

What Levetiracetam Strides oral solution looks like and contents of the pack

Levetiracetam Strides 100 mg/ml oral solution is a clear liquid.

The 300 ml glass bottle of Levetiracetam Strides oral solution (for children aged 4 years and above, adolescents and adults) is packed in a cardboard box containing a 10 ml oral syringe (graduated every 0.25 ml) and an adaptor for the syringe.

The 150 ml glass bottle of Levetiracetam Strides oral solution (for infants and young children aged from 6 months to less than 4 years) is packed in a cardboard box containing a 3 ml oral syringe (graduated every 0.1 ml) and an adaptor for the syringe.

The 150 ml glass bottle of Levetiracetam Strides oral solution (for infants aged 1 month to less than 6 months) is packed in a cardboard box containing a 1 ml oral syringe (graduated every 0.05 ml) and an adaptor for the syringe.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Strides Arcolab International Limited

Unit 4, Metro Centre Tolpits Lane Watford, Hertfordshire WD18 9SS UNITED KINGDOM

Manufacturer Beltapharm S.p.A

Via Stelvio 66

Cusano Milanino (MI) - 20095 ITALY

Other formats: To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 Please be ready to give the following information:

Product name    Reference number

Levetiracetam Strides 100mg/ml Oral Solution PL 28176/0163 This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in 06/2016

Dimension: 380 x 310 mm

Font: Times New Roman Font Size: 9 pt

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